Food Standards of Identity Modernization; Pasteurized Orange Juice

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 146</CFR> <DEPDOC>[Docket No. FDA-2022-P-1668]</DEPDOC> <RIN>RIN 0910-AI98</RIN> <SUBJECT>Food Standards of Identity Modernization; Pasteurized Orange Juice</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is proposing to amend the standard of identity for pasteurized orange juice (POJ) by lowering the minimum orange juice soluble solids content from 10.5° to 10° Brix. We tentatively conclude that this proposed amendment will promote honesty and fair dealing in the interest of consumers and provide industry greater flexibility in the manufacture of pasteurized orange juice. This action, if finalized, will respond to a citizen petition submitted by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the proposed rule must be submitted by November 4, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 4, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2022-P-1668 for “Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Vivien Yan Peng, Office of Nutrition and Food Labeling, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Keronica C. Richardson, Office of Policy, Regulations, and Information, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Proposed Rule</FP> <FP SOURCE="FP1-2">B. Legal Authority</FP> <FP SOURCE="FP1-2">C. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation</FP> <FP SOURCE="FP1-2">B. History of the Rulemaking</FP> <FP SOURCE="FP-2">III. Legal Authority</FP> <FP SOURCE="FP-2">IV. Description of the Proposed Rule</FP> <FP SOURCE="FP1-2">A. Scope/Applicability</FP> <FP SOURCE="FP1-2">B. Amending the Standard of Identity Regulation To Reduce the Minimum Brix Level</FP> <FP SOURCE="FP-2">V. Proposed Effective/Compliance Dates</FP> <FP SOURCE="FP-2">VI. Questions About POJ SOI</FP> <FP SOURCE="FP-2">VII. Preliminary Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">VIII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">X. Federalism</FP> <FP SOURCE="FP-2">XI. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XII. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Proposed Rule</HD> FDA is proposing to revise the standard of identity (SOI) for POJ established at 21 CFR 146.140 (§ 146.140). The SOI currently requires that finished POJ contain not less than 10.5 percent by weight of orange juice soluble solids, exclusive of the solids of any added optional sweetening ingredients (§ 146.140(a)). The percentage soluble solids by weight of an aqueous solution ( <E T="03">e.g.,</E> grams of sucrose in 100 grams of solution at 68 degrees F) can be expressed as Brix or degree of Brix (° Brix). The current SOI for POJ therefore requires a minimum orange juice soluble solids of 10.5° Brix. The proposed rule, if finalized, will amend the POJ standard by lowering the minimum orange juice soluble solids from 10.5° to 10° Brix for finished POJ. We tentatively conclude that this proposed amendment will promote honesty and fair dealing in the interest of consumers and provide greater flexibility in the manufacture of POJ (see section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341)). <HD SOURCE="HD2">B. Legal Authority</HD> We are issuing this proposed rule consistent with our authority in sections 401 and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341, 371). <HD SOURCE="HD2">C. Costs and Benefits</HD> The proposed rule, if finalized, would not require firms in the POJ industry to change their manufacturing processes or behavior in any way. Qualitative benefits include flexibility for manufacturers, flexibility of product choice for consumers, and potential sustainability for manufacturers in the face of disease or climate impacts. We note specifically that the proposed rule does not require any behavioral changes on the part of manufacturers, as it provides manufacturers with greater flexibility rather than imposing any restrictions. The proposed changes would provide for a wider range of products to be marketed as POJ. No changes would be required for products that already meet the existing POJ standard. Therefore, any changes made by manufacturers of POJ would be voluntary. The proposed rule, if finalized, would not impose any compliance costs to firms. We estimate cost savings to manufacturers due to substitution to cheaper inputs. The annualized costs would range from −$14.7 million to −$106.7 million, with a primary estimate of −$52.3 million, at a 7 percent discount rate, and from −$14.8 million to −$107.0 million, with a primary estimate of −$52.5 million, at a 3 percent discount rate. <HD ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 43k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━